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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002062
Receipt No. R000002515
Scientific Title Randomized controlled study for an effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients
Date of disclosure of the study information 2009/06/10
Last modified on 2009/06/10

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Basic information
Public title Randomized controlled study for an effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients
Acronym Effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients
Scientific Title Randomized controlled study for an effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients
Scientific Title:Acronym Effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of postprandial monitoring with oral hypoglycemic agent in type 2 diabetic patients.
This study adopt multicenter, open label, randomized controlled design. Subjects are randomized to two groups:one group use the blood glucose-monitoring device, and check the postprandial blood glucose; the control group has standard diabetes treatment.
The primary efficacy parameter is improvement of HbA1c, glucose and lipid metabolism, inflammation, daily care include diet therapy. Secondary efficacy variables include cost reduction by convalescence improvement.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c, glucose and lipid metabolism, inflammation, daily care include diet therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Operation of SMBG
Interventions/Control_2 The control group of SMBG(Measurement:post for a fixed period of time)

Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria HbA1c 5.8-9.0 in non-insulin type 2 diabetic patients
Key exclusion criteria Insulin patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Munehide Matsuhisa
Organization Osaka University School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 2-2, yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3633
Email

Public contact
Name of contact person
1st name
Middle name
Last name Munehide Matsuhisa
Organization Osaka University School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 2-2, yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3633
Homepage URL
Email

Sponsor
Institute Department of Endocrinology and Metabolism, Osaka University School of Medicine
Institute
Department

Funding Source
Organization johnson and johnson
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2007 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 10 Day
Last modified on
2009 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002515

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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